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NCT05325632 · ClinicalTrials.gov registry record · Phase 2
Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab
A Phase 2 study of HER2-positive Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 1
- Study location
NCT05325632: Recruiting Phase 2 study of HER2-positive Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT05325632 is a Phase 2 study of HER2-positive Breast Cancer that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 53 participants, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05325632, a Phase 2 study of HER2-positive Breast Cancer, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to find out if an investigational drug called Dendritic Cell (DC1) vaccine added to standard neoadjuvant (given before main treatment) therapy can help people with HER2 (human epidermal growth factor receptor 2) positive breast cancer.
Primary Outcome
Immunogenicity: will be characterized by quantifying CD4TH1 response via ELISPot. ELISPot is an enzyme-linked immunospot assay. It is a highly sensitive immunoassay that measures the frequency of cytokine-secreting cells at the single-cell level.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Paclitaxel
- DRUG Pertuzumab
- BIOLOGICAL HER-2 pulsed DC1
- PROCEDURE Resection surgery
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2021-10-28 |
| Est. Completion | 2027-09 |
| Phase | Phase 2 |
What NCT05325632 shows while recruiting
NCT05325632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (77% lower).
The record links to 1 condition, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Trastuzumab is the first listed.
NCT05325632 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05325632 about?
NCT05325632 is a clinical study titled "Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab". The purpose of the study is to find out if an investigational drug called Dendritic Cell (DC1) vaccine added to standard neoadjuvant (given before main treatment) therapy can help people with HER2 (human epidermal growth factor receptor 2) positive breast cancer.
What is the current status of trial NCT05325632?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2021-10-28. Estimated completion is 2027-09.
What conditions does trial NCT05325632 study?
This clinical trial studies the following conditions: HER2-positive Breast Cancer.
What interventions are being tested in trial NCT05325632?
The interventions under investigation include: Trastuzumab (DRUG), Paclitaxel (DRUG), Pertuzumab (DRUG), HER-2 pulsed DC1 (BIOLOGICAL), Resection surgery (PROCEDURE).
Who is sponsoring clinical trial NCT05325632?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05325632 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-positive Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05325632's enrollment target sits among peer trials
53 32nd of 58 higher than 27 of 58 other HER2-positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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